The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.
The U.S. Federal Trade Commission (FTC) and the Department of Justice (DOJ) have issued the final version of their updated merger guidelines for corporations, concluding a process that took a scant six months to complete following the issuance of the draft.
The FDA’s ongoing efforts to modernize the 510(k) program produced three draft guidances in the waning days of fiscal year 2023, one of which is a draft for the scenarios in which clinical data would be required for a 510(k) application.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
